Abstract: An improved cathodic iontophoresis electrode assembly (8, 38) is provided having a reducible cathodic electrode (12,22) and a drug reservoir (14, 24) containing an anionic drug. The cathodic electrode (12, 22) is separated from the drug reservoir (14, 24) by means of a layer (30) of a cation exchange material. The cation exchange material is loaded with cations which are able to react with anions produced during reduction of the electrode (12, 22) to form an electrically neutral or substantially insoluble (eg, water insoluble) compound. The cathodic electrode (12, 22) is preferably composed of silver chloride which produces chloride ions during reduction. The cation exchange material is preferably loaded with silver or copper cations which react with the chloride ions to produce a neutral and relatively insoluble metal chloride salt.

Abstract: A selectively permeable membrane (14) is positioned between the agent reservoir (15) and the electrode (11) of a donor electrode assembly (8) in an iontophoretic delivery device (10). Optionally, an electrolyte reservoir (13) is positioned intermediate the electrode (11) and the agent reservoir (15). In certain embodiments, the membrane (14) is permeable to species of less than a predetermined molecular weight and substantially less permeable to species of greater than the predetermined molecular weight. The agent is capable of dissociating into agent ions and counter ions.

Abstract: An iontophoretic agent delivery device having a simplified structure and ease of manufacture. The device utilizes an electrical pathway comprising a source of electrical energy and an output means. The electrical pathway is disposed upon one of the two sides of a flexible, non-conductive substrate (e.g., a film). The output means of the pathway are connected directly or indirectly, e.g., by means of an electrically conductive adhesive tape, to the remaining components of the device such as current distribution members, lead wires, or electrodes. In this arrangement, the circuit is inverted from that of conventional devices. Economical, reel-to-reel methods of manufacturing a one-sided iontophoretic circuit apparatus of the invention are disclosed.

Abstract: A transdermal drug delivery device (20) is provided having both an active drug reservoir (24) and a passive drug reservoir (26). Drug is actively delivered by iontophoresis from the active drug reservoir (24) by an electric field generated by a power source (21). Simultaneously, drug is delivered from passive reservoir (26) by passive (i.e., non-electrically assisted) diffusion. In one embodiment, the passive drug reservoir (26) is electrically insulated from the active drug reservoir (24). In a second embodiment, both the active and the passive drug are contained in the same reservoir (34). In the second embodiment, the active drug is ionizable while the passive drug is non-ionizable. Most preferably, the active drug is an ionizable form (i.e., a salt form) of the passive drug.

Abstract: Apparatus (11) for delivery of a medicament, drug or other therapeutic agent transdermally to a body by iontophoresis is provided. The apparatus (11) provides a means (13) for measuring and displaying the cumulative amount of the medicament delivered to the body by monitoring the amount of a metal, initially present at the anode (45), that is transferred to the cathode (41) in a subsidiary electrolyte cell (47) through which the drive current for the apparatus (11) passes. Optionally, the apparatus also provides a plurality of light emitting devices (63-1) that display a measure of the cumulative amount of medicament delivered, by use of visually distinguishable light colors or by use of binary encoding in the light display.

Abstract: A dry-state iontophoretic drug delivery device (10, 20) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a passageway (21, 22) is provided through the backing layer (13) and the electrode layer (11, 12) of both the donor electrode assembly (8) and the counter electrode assembly (9). Water or other liquid can be introduced through these passageways (21, 22) in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10). In another embodiment of the device (20), the drug and electrolyte reservoirs (15, 16) are initially separated from their respective electrodes (11, 12). After the reservoirs (15, 16) are hydrated, they are placed in electrical contact with their respective electrodes (11, 12). By joining the reservoir (15, 16) to the electrode (11, 12) after hydration occurs, delamination problems are reduced.

Abstract: An iontophoretic drug-delivery device incorporating a power supply which minimizes the cost of the batteries needed by operating the batteries in a series configuration at the start of delivery, when the patient's skin resistance is high, and by switching the batteries into a parallel configuration when skin resistance drops. An automatic switching circuit for achieving this transition is included.

Abstract: A two phase adhesive matrix for use in an electrically powered iontophoretic delivery device is provided. The adhesive matrix comprises an adhesive hydrophobic polymer phase and about 15 to 60 wt. % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase. The hydrophilic phase forms upon hydration an interconnecting network of aqueous pathways for passage of the agent through the adhesive. The adhesive can be used to adhere an electrode assembly of an iontophoretic delivery device to a body surface such as skin or a mucosal membrane. Alternatively, the adhesive can be used to adhere together two or more elements of an iontophoretic delivery device.

Abstract: A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.

Abstract: A dry-state iontophoretic drug delivery device (10, 70, 80) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. A liquid-containing pouch (21, 22) is provided. In certain embodiments the liquid is contained in breakable capsules within the pouch. Water or other liquid can be released from the capsules in the pouch by squeezing or flexing the pouches (21,22). Alternatively, the liquid can be released from the pouches (21,22) using pouch piercing pins (36,37). The liquid released from the pouches (21,22) hydrates the drug and electrolyte reservoirs (15, 16) and activates the device. In another embodiment, the device (20, 20a) has liquid-containing gel layers (31,32) which are initially separated from their respective electrode assemblies (8, 9). Liquid-wicking pathways (27,28) are provided to carry the liquid from the gel layers (31,32) to the drug and electrolyte layers (15, 16).

Abstract: An iontophoretic agent delivery device having a simplified structure and ease of manufacture. The device utilizes an electrical pathway comprising a source of electrical energy and an output means. The electrical pathway is disposed upon one of the two sides of a flexible, non-conductive substrate (e.g., a film). The output means of the pathway are connected directly or indirectly, e.g., by means of an electrically conductive adhesive tape, to the remaining components of the device such as current distribution members, lead wires, or electrodes. In this arrangement, the circuit is inverted from that of conventional devices. Economical, reel-to-reel methods of manufacturing a one-sided iontophoretic circuit apparatus of the invention are disclosed.

Abstract: An iontophoretic agent delivery device, having a layered structure and peripheral insulation, wherein ion transport occurs through two opposing surfaces of said device. The device is especially suited to agent delivery through body surfaces exposed to body fluids. A method of delivering an agent through a body surface exposed to body fluids is also disclosed.

Abstract: A dry-state iontophoretic drug delivery device (10, 70, 80) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. A liquid-containing pouch (21, 22) is provided. In certain embodiments the liquid is contained in breakable capsules within the pouch. Water or other liquid can be released from the capsules in the pouch by squeezing or flexing the pouches (21,22). Alternatively, the liquid can be released from the pouches (21,22) using pouch piercing pins (36,37). The liquid released from the pouches (21,22) hydrates the drug and electrolyte reservoirs (15, 16) and activates the device. In another embodiment, the device (20, 20a) has liquid-containing gel layers (31,32) which are initially separated from their respective electrode assemblies (8, 9). Liquid-wicking pathways (27,28) are provided to carry the liquid from the gel layers (31,32) to the drug and electrolyte layers (15, 16).

Abstract: Apparatus (11) for delivery of a medicament, drug or other therapeutic agent transdermally to a body by iontophoresis is provided. The apparatus (11) provides a means (13) for measuring and displaying the cumulative amount of the medicament delivered to the body by monitoring the amount of a metal, initially present at the anode (45), that is transferred to the cathode (41) in a subsidiary electrolyte cell (47) through which the drive current for the apparatus (11) passes. Optionally, the apparatus also provides a plurality of light emitting devices (63-1) that display a measure of the cumulative amount of medicament delivered, by use of visually distinguishable light colors or by use of binary encoding in the light display.

Abstract: A two phase adhesive matrix for use in an electrically powered iontophoretic delivery device is provided. The adhesive matrix comprises an adhesive hydrophobic polymer phase and about 15 to 60 wt % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase. The hydrophilic phase forms upon hydration an interconnecting network of aqueous pathways for passage of the agent through the adhesive. The adhesive can be used to adhere an electrode assembly of an iontophoretic delivery device to a body surface such as skin or a mucosal membrane. Alternatively, the adhesive can be used to adhere together two or more elements of an iontophoretic delivery device.

Abstract: An adhesive composition suitable for use as an in-line contact adhesive for electrotransport drug delivery systems.

Abstract: A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.

Abstract: A transdermal drug delivery device (20) is provided having both an active drug reservoir (24) and a passive drug reservoir (26). Drug is actively delivered by iontophoresis from the active drug reservoir (24) by an electric field generated by a power source (21). Simultaneously, drug is delivered from passive reservoir (26) by passive (i.e., non-electrically assisted) diffusion. In one embodiment, the passive drug reservoir (26) is electrically insulated from the active drug reservoir (24). In a second embodiment, both the active and the passive drug are contained in the same reservoir (34). In the second embodiment, the active drug is ionizable while the passive drug is non-ionizable. Most preferably, the active drug is an ionizable form (i.e., a salt form) of the passive drug.

Abstract: A membrane capable of controlling the rate at which an agent is released from an iontophoretic delivery device is provided. The membrane inhibits agent release from the delivery device when no electrical current is flowing and yet provides minimal impedance to electrically-assisted agent delivery. The membrane is useful both as a control membrane in an iontophoretic agent delivery device and as a test membrane for testing the performance characteristics of an iontophoretic agent delivery device in vitro.

Abstract: A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.